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Recruiting NCT07406282

A Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology Clinics

— Observational Prostatic Neoplasms Metastatic Hormone-Sensitive Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Darolutamide, Abiraterone acetate, Enzalutamide, Apalutamide.
Who it may be relevant to
Registry conditions: Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA

Overview

Prostate cancer is the most common non-skin cancer among men in the United States. For some men, the cancer has already spread to other parts of the body at the time of diagnosis; this is called metastatic hormone-sensitive prostate cancer (mHSPC). Treatment for mHSPC has advanced significantly, with new standards of care involving androgen deprivation therapy (ADT) combined with drugs known as androgen receptor pathway inhibitors (ARPIs), sometimes alongside chemotherapy like docetaxel. Darolutamide is an ARPI that is approved by the FDA for treating mHSPC in a "triplet" combination with ADT and docetaxel. It is also used in a "doublet" combination with ADT alone. However, there is limited information on how darolutamide is used in real-world clinical settings for this condition, which creates a gap in knowledge for making treatment decisions. This study aims to fill that gap by analyzing real-world data from electronic medical records. The primary goal is to describe the characteristics of patients with newly diagnosed mHSPC who are treated with darolutamide (either as a doublet or triplet) in urology clinics across the US. The study will also examine drug use patterns and clinical outcomes for these patients. Additionally, the study will explore the characteristics of patients treated with other ARPIs (abiraterone acetate, enzalutamide, and apalutamide) and assess the feasibility of creating matched patient groups for future comparative research. Data will be collected retrospectively from a large network of community urology practices in the US.

Interventions

  • Drug Darolutamide
    Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
  • Drug Abiraterone acetate
    Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
  • Drug Enzalutamide
    Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer
  • Drug Apalutamide
    Androgen receptor pathway inhibitor for treatment of metastatic hormone-sensitive prostate cancer

Primary outcome measures

  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): age [Time frame: Baseline]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): age [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Concomitant Medication [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Concomitant Medication [Time frame: Baseline]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): ethnicity [Time frame: Baseline]
  • Describe baseline demographic of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): ethnicity [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Charlson Comorbidity Index [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Charlson Comorbidity Index [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT + docetaxel (triplet therapy): Gleason Score [Time frame: Baseline]
  • Describe baseline clinical characteristics of de novo mHSPC patients receiving darolutamide + ADT (doublet therapy): Gleason Score [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • Male patients with evidence of de novo mHSPC during the study period
  • Initiation of ARPI therapy during the patient identification period and within ±90 days from the mHSPC diagnosis
  • Age ≥18 years at index date (ARPI initiation for mHSPC)
  • Initiation of ADT and/or docetaxel therapy within ±90 days from index date
  • At least 90 days of EMR activity prior to the index date
  • At least 90 days of EMR activity post-index, unless the patient died earlier.

Exclusion criteria

  • History of other primary cancers (except non-melanoma skin cancer)
  • Use of PARP inhibitors, chemotherapy (other than docetaxel), immunotherapy or radiopharmaceuticals prior to index date
  • Evidence of castration resistance (CR) flag in the database any time before the index date or up to 90 days after the de novo mHSPC diagnosis
  • Clinical trial participation during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Precision Point Specialty LLC PPS Analytics, a Specialty Networks LLC Company — Cleveland

Identifiers

NCT: NCT07406282 · 23094

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗